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Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

NCT00592683 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-04-06

Study results available
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Summary

This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows:

Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD

Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment

Conditions

  • Pediatric Bipolar Disorder

Interventions

DRUG

Aripiprazole

tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks

DIETARY_SUPPLEMENT

fish oil

1600mg (4 capsules) daily for 12 weeks

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet Wozniak, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00592683 on ClinicalTrials.gov